Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention

Recruiting

• Conditions: Abdominal Distention

• Registration Number: NCT06285734
• Lead Sponsor: Shandong University

Brief Summary

Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.

Detailed Description

Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. And the prevalence of abdominal distension is high in the population. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between the clinical features such as severity, location, and frequency of abdominal distension and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-02-29
• Study Start: 2024-03-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-07
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

1. Patients aged 18 to 70 years.
2. Patients presenting with the primary complaint of abdominal bloating and/or abdominal distension, or those exhibiting abdominal distension with prominence over other symptoms.

Exclusion Criteria

1. Patients who are pregnant or lactating.
2. Patients have history of gastrointestinal malignancy or gastrointestinal surgery.
3. Patients manifesting food intolerance or presenting with a confirmed diagnosis or suspicion of lactose intolerance.
4. Patients with urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.), or other diseases outside the digestive system.
5. Patients who used antibiotics or microecological agents or underwent endoscopic examination within two weeks.
6. Patients with a medication history encompassing motility enhancers, secretory enhancers, antifoaming agents, spasmolytics, opioids, and antidepressants within the past week.
7. Patients who are unwilling or incapable to provide informed consents.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive rate of SIBO in patients with abdominal distension	2024-03-01 to 2025-08-01	Detect the positive rate of SIBO in patients with abdominal distension by breath test

Secondary Outcome Measures

Name	Time	Method
Positive rate of abnormal OCTT in patients with abdominal distension	2024-03-01 to 2025-08-01	Detect the positive rate of abnormal OCTT in patients with abdominal distension by breath test
Correlation between clinical features of patients with abdominal distension and SIBO	2024-03-01 to 2025-08-01	Analyze the correlation between clinical features of patients with abdominal distension and SIBO
Correlation between clinical features of patients with abdominal distension and OCTT	2024-03-01 to 2025-08-01	Analyze the correlation between clinical features of patients with abdominal distension and OCTT

Trial Locations

Locations (1)

Gastroenterology Department of Qilu Hospital; 🇨🇳 Jinan, Shandong, China